Friday, December 27, 2013

No Causation, No Claim

Today we feature a case that exemplifies two principles
that we routinely encounter in our practices, but rarely at the same time.First, there is no more sympathetic plaintiff
than a disabled military veteran.We
come across and write on cases involving sad facts with some regularity, which
is an occupational hazard of our practice in the drug and medical device
arena.The most compelling cases we see
involve patients who have experienced actual injuries, a fact that we always
bear in mind as we report on what the law is and what we believe the law should
be.Moreover, while everyone has a point
of view on what kinds of cases provoke the greatest sympathy, we have learned
in our many years on Reed Smith’s Pro Bono Committee that disabled veterans
garner the broadest imaginable support.Some
people champion children’s issues; others promote immigration reform, or
perhaps they favor housing rights.But
everyone gets behind programs supporting disabled veterans.And rightfully so. Today’s veterans are young men and women who
have completed their service and have their whole lives ahead of them,
often with significant challenges.

The second principle that today’s case brings to mind is
that civil litigation cannot and should not provide a remedy if the law and
facts are not there to support one, no matter how sympathetic the plaintiff may
be.The district court’s order granting
summary judgment in Carnes v. Eli Lilly
& Co., No. 0:13-591-CMC, 2013 U.S. Dist. LEXIS 176201 (D.S.C. Dec. 16,
2013), brings together these two principles by presenting a disabled Army
veteran and physicians who prescribed prescription drugs with full knowledge of
all the relevant risks.In Carnes, the plaintiff injured his spinal
cord while attempting to rescue fellow soldiers in Iraq, and as a result he is
wheelchair bound, has significant physical limitations, and suffers from
chronic pain.Id. at *1.One physician
prescribed Lyrica, an antiepileptic drug indicated for treating pain associated
with spinal cord injury, but after about three years on the drug, the plaintiff
asked to stop.Id. at *2.The doctor
therefore prescribed Cymbalta, which is a serotonin and norepinephrine reuptake
inhibitor that is also indicated for treatment of chronic pain.After a few months, the plaintiff changed
doctors and asked to switch his medication again because he thought the drug
was causing him to gain weight.Id. at *2.The new doctor therefore tapered the
plaintiff off Cymbalta and restarted Lyrica.Id. at **2-3.According to the doctor, she tapered the
plaintiff’s dose “to avoid potential side effects from stopping Cymbalta
suddenly.”Id. at *3.

As the second doctor’s remarks suggest, discontinuing
Cymbalta can result in withdrawal-like symptoms, which the doctor knew about and
which the product's label disclosed at all relevant times.Id.
at **4-5.The physician who first
prescribed the drug similarly was aware of the risk of withdrawal symptoms
“having learned about them in medical school, during his residency, and from
patients who experienced withdrawal symptoms.”Id. at *16.Alas, the plaintiff experienced
post-discontinuation symptoms that he attributed to the drug, including sharp
headaches, nightmares, anger, and shaking.He therefore sued the drug’s manufacturer, who moved for summary
judgment under South Carolina’s learned intermediary doctrine.

The district court’s order granting summary judgment is
useful on multiple levels.To start, the
court observed that “[p]rescription drugs are neither defective nor
unreasonably dangerous if accompanied by proper direction and warnings,” which
reiterates to us that South Carolina applies comment k across the board to all
prescription drug cases.Id. at *9.In addition, the court confirmed that South
Carolina applies the learned intermediary doctrine in prescription drug cases and
that “a plaintiff must not only show that the drug manufacturer’s warning was
inadequate, but ‘also that the inadequacy of the warning was the proximate
cause of the plaintiff’s injury.’”Id. at *10.Lots of courts have made statements like this
under various states’ laws, and our readers will find the statement a familiar
truth.This court, however, went a
helpful step further and explained exactly what warnings causation means, i.e., that different or additional information
would have changed the physician’s prescribing decision.As the court put it,

In light of the learned intermediary doctrine, ‘the burden
remains on the plaintiff to demonstrate that the additional non-disclosed risk
was sufficiently high that it would have changed the treating
physician’s decision to prescribe the product for the plaintiff.’”

Id at *10.This is not an extraordinary holding, but it
is reassuring to see a court lay out the rule so clearly and completely.We have often said
that warnings causation is a powerful element because it forecloses liability
for failure to warn in the abstract.Maybe the labeling could reasonably have been stronger or more complete
in some conceivable way.Or maybe it
could not have.We have no reason to
believe that the warnings at issue in Carnes
were in any way less than adequate, but either way, we do know that the court
asked the correct question:Would additional
warnings have made any difference for this actual plaintiff vis-à-vis his
physician’s decision to prescribe the drug?

This court clearly understood the law and properly placed
the burden on the plaintiff.With regard
to the doctor who initially prescribed the drug, the plaintiff argued that
certain study results should have been disclosed in the label, but the doctor “testified
that had he been provided the warning Plaintiffs allege would have been
adequate, he still would have prescribed.”Id. at *14.There is no more clear break in the causal
chain than this, particularly where the plaintiff has set forth specific
information that the alternate “adequate” label allegedly should have included.We think every plaintiff claiming inadequate
warnings should have to set forth a proposed alternative, but many get away
with leveling only vague criticisms.

Nor was the plaintiff able to salvage his warnings-based
claims by taking the doctor out of the equation.The plaintiff argued that he as a patient
would not have taken the drug if he personally had known about the risk of
withdrawal, thus attempting “[w]ithout any legal authority . . . to displace
the learned intermediary doctrine.”Id. at *14.But the court correctly ruled that the
law “requires the court to focus on the physician’s decision to prescribe the
drug.”Id. at *15 (emphasis added).With regard to the doctor who tapered the plaintiff off Cymbalta, she
too testified that even if the label had included information that the
plaintiff said should have been there, she still would have gradually reduced
his dose, just as she did when she made her actual treating decisions.Id.
at *21.Case closed.

The court’s disciplined order is all the more admirable
because it was filed nine days before Christmas, a time of year when the
sympathy toward a disabled war hero might have been heightened.However, in light of the evidence as the
court described it, this is the correct result based on correct reasoning, and
the court’s very clear restatement and application of the learned intermediary
doctrine is a good example to file away for future use.

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About

This blog contains the personal views of the Blogging Team identified below (and of any authors of guest posts) concerning various topics that arise in the defense of pharmaceutical and medical device product liability litigation. Please read the DISCLAIMER about the nature of this blog, and understand that you are accepting its terms, before reading any of the posts here.

Blogging Team

James M. Beck is Counsel resident in the Philadelphia office of Reed Smith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). he wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He can be reached at jmbeck@reedsmith.com.

Stephen McConnell has authored articles and chapters on product liability (though nothing as snappy or authoritative as Beck's book) and has tried drug and device cases that managed to evade the pretrial gauntlet. He is a partner in the Philadelphia office of Reed Smith and can be reached at smcconnell@reedsmith.com.

Michelle Hart Yeary is a seasoned products liability litigator who focuses on attempting to bring order to the chaos that is mass torts, concentrating on the practicalities and realities of defending coordinated and multidistrict litigation. She is counsel in the Princeton office of Dechert LLP and can be reached at michelle.yeary@dechert.com.

John J. Sullivan is a products liability and commercial litigator, having authored articles on mass torts and securities litigation and presented on trial advocacy. He is experienced in mass tort litigation, with a particular emphasis on scientific and regulatory issues, as well as having experience in complex commercial, securities class action and corporate governance litigation. He is a partner in the downtown Manhattan and New Jersey offices of Cozen O'Connor and can be reached at jsullivan@cozen.com.

Eric L. Alexander is a partner in Reed Smith’s Washington office. He has spent almost his entire career representing drug and device companies in product liability litigation from discovery through motions, trials, and appeals, usually on the right side of the v. He is particularly interested in medical and proximate cause and the intersection of actual regulatory requirements and the conduct that plaintiffs allege was bad, which covers quite a bit. He can be reached at ealexander@reedsmith.com.

Steven J. Boranian is a partner in Reed Smith’s San Francisco office, where he focuses his practice on representing drug and medical device companies in product liability and other kinds of litigation. He has handled drug and device matters from pre-litigation demands to appeals and all points in between, with particular interests in “mass” proceedings and class actions, to the extent the latter should ever be allowed in the drug and medical device context. He can be reached at sboranian@reedsmith.com.

Rachel B. Weil is counsel in Reed Smith’s Philadelphia office. Except for a brief, misguided trip to the “dark side,” Rachel has spent her whole career defending drug and device manufacturers in product liability litigation and in government actions arising from such litigation. While she laments the single-plaintiff drug cases of her youth, she loves nothing better than a good mass tort. She can be reached at rweil@reedsmith.com
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